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The Alport syndrome pipeline drugs market research report includes an assessment of the disease epidemiology, leading marketed products, late-to-mid-stage pipeline products with Phase Transition Success Rate (PTSR), and Likelihood of Approval (LoA) for Alport syndrome. The report also analyzes the clinical and commercial landscapes of Alport syndrome, as well as an assessment of deals, future market catalysts, key market players, and the future competitive environment. Alport syndrome (AS) is a genetically and phenotypically heterogeneous, progressive hereditary renal disease that is characterized by sensorineural hearing loss and ocular abnormalities.
Reata Pharmaceuticals’ Phase II pursuit of bardoxolone in focal segmental glomerulosclerosis (FSGS) may be thwarted given proteinuria increases seen in other kidney disorder trials.
FSGS is characterised by scar tissue formation on glomeruli, small blood vessels which filter waste from the blood, and is associated with high protein levels in urine.
A reduction in proteinuria, or protein in the urine, is an important surrogate measure for treating primary FSGS and while experts said primary FSGS’ pathophysiology is not well Alport syndrome understood, they noted proteinuria associated with bardoxolone treatment in other rare kidney disorders, such as IgA nephropathy, is detrimental to treating FSGS.
This contradictory observation coupled with a checkered history of the drug’s failure to be approved in other indications made some experts wary about its FSGS prospects.
The Phase II Phoenix study (NCT03366337) is enrolling patients with rare kidney disorders like primary FSGS, IgA nephropathy, chronic kidney diseases (CKD) associated with Type I diabetes (T1D-CKD) and autosomal dominant polycystic kidney disease, split into separate cohorts. Twelve-week data from the FSGS cohort is expected in 1H19, according to a January company presentation.
The company announced positive data from the T1D-CKD and IgA nephropathy cohorts in September 2018, resulting in a 7.6% positive stock movement and analysts deem the FSGS data as material to Reata.
Reata’s market capitalisation is $2.2 billion. Global revenues for bardoxolone across all indications in 2024 are estimated to be $1.2 billion, according to GlobalData.